Early access
Sign in
Active, not recruitingNo phase

Leiden Thrombosis Recurrence Risk Prevention

Key facts

Who runs it
Leiden University Medical Center
Where
Netherlands19 sites in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
608 people, planned
Started
18 Jun 2021
Expected to end
1 Jun 2027
Type of study
Interventional, 4 groups
Treatments tested
  • Randomised treatment advice (discontinue vs continue after 3 months)
  • VTE-BLEED score
  • L-TRRiP score
  • Advise to continue anticoagulant treatment after 3 months
  • Advise to discontinue anticoagulant treatment after 3 months
Record updated
20 February 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Provision of informed consent prior to any study specific procedures
  • Be diagnosed with a first confirmed symptomatic deep vein thrombosis (including distal vein thrombosis, in Dutch: 'kuitvenetrombose') or pulmonary embolism with an indication for treatment with anticoagulant therapy for at least 3 months as prescribed by their treating physician
  • Be aged 18 years or above

Who cannot take part

  • Patients with active cancer (i.e. cancer diagnosis within six months before VTE (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before the venous thromboembolism was diagnosed) or antiphospholipid syndrome
  • Patients with a strong indication for long-term antiplatelet therapy despite oral anticoagulation (e.g. those with recent STEMI)
  • Patients with COVID-19 associated VTE (hospital admission because of COVID-19 <3 months before the VTE) or vaccine-induced immune thrombotic thrombocytopenia (VITT)
  • Patients in whom the risk of bleeding is deemed extremely high by the treating physician, necessitating discontinuation of anticoagulant treatment for the first VTE after the initial 3 months or even during the initial 3 months
  • Patients who need to continue anticoagulant treatment for another indication (e.g. atrial fibrillation)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this clinical trial is to evaluate tailored duration of long-term anticoagulant treatment after a first venous thromboembolism based on individualized risk assessments of recurrent VTE and major bleeding risks.

Read full original descriptionShow less

Participants will be asked to fill in a questionnaire and take a buccal swab, which are used for an individual estimation of the risks of recurrent VTE and bleeding. Based on these risks a treatment advise will be made, or randomised in a subgroup of patients.

The 4 groups in the trial

  • Continue anticoagulationOther group

    Patients with high recurrent VTE risk and low major bleeding risks are advised to continue anticoagulant therapy.

    Treatment: VTE-BLEED score, L-TRRiP score, and Advise to continue anticoagulant treatment after 3 months

  • Discontinue anticoagulationOther group

    Patients with low recurrent VTE risk are advised to discontinue anticoagulant therapy.

    Treatment: VTE-BLEED score, L-TRRiP score, and Advise to discontinue anticoagulant treatment after 3 months

  • Randomised to continue anticoagulationOther group

    Patients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy.

    Treatment: Randomised treatment advice (discontinue vs continue after 3 months), VTE-BLEED score, and L-TRRiP score

  • Randomised to discontinue anticoagulationOther group

    Patients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy.

    Treatment: Randomised treatment advice (discontinue vs continue after 3 months), VTE-BLEED score, and L-TRRiP score

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Leiden Thrombosis Recurrence Risk Prevention: Tailored Treatment After a First Venous Thromboembolism
Record updated
20 February 2026